Medical Device Alerts issued in February 2020

Alerts were issued about CME T34 and T34L (T60) ambulatory syringe pumps, Cardinal Health tympanic thermometers, t:slim X2 insulin pump, and Mavidon skin preparation electrode gels.

Medical Device Alerts issued in February 2020

In this monthly update, we highlight selected Medical Device Alerts and notices that have been issued recently by MHRA. Please note, this is not an exhaustive list of medical device alerts. For all Medical Device Alerts from MHRA, see Alerts and recalls for drugs and medical devices.

All T34 and T34L (T60) ambulatory syringe pumps – check pumps before each use due to risk of under-infusion and no alarm (MDA/2020/007). Issued 25 February 2020. Manufactured by CME (a BD company) – updated advice to address ‘wear and tear’ of the syringe pump motor block, which may lead to under-infusion. Inspect the pump before each use and if white plastic debris is present on the lead screw, immediately stop using the pump and send for repair.

Tympanic thermometers – revision of the calibration frequency of Cardinal Health Genius 2 and Genius 3 models. Issued 27 February 2020. Manufactured by Cardinal Health – calibration period revised to 25 weeks instead of yearly to ensure these thermometers remain within their accuracy range and reduce the risk of misdiagnosis or delay in treatment.

t:slim X2 insulin pump – discard or destroy defective mains (A/C) power adapters (MDA/2020/005). Issued 5 February 2020. Manufactured by Tandem Diabetes Care – an exposed component may cause an electrical shock to the user or patient. Identify patients supplied with affected insulin pumps and ensure they receive an replacement adaptor.

Skin preparation electrode gel: recall of all lots of LemonPrep, PediaPrep, Wave Prep and Cardio Prep due to risk of contamination and transmission of infection (MDA/2020/004). Issued 5 February 2020. Manufactured by Mavidon – products may be contaminated with the micro-organism Burkholderia cepacia, leading to an infection risk to patients. All products made at this site are being recalled.

Article citation: Drug Safety Update volume 13, issue 8: March 2020: 7.

Published 18 March 2020